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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
Daiichi Sankyo
Express Scripts
Teva
Harvard Business School
Merck
Accenture
Boehringer Ingelheim
Fish and Richardson

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021880

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NDA 021880 describes REVLIMID, which is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are twenty-seven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the REVLIMID profile page.

The generic ingredient in REVLIMID is lenalidomide. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for 021880
Tradename:REVLIMID
Applicant:Celgene
Ingredient:lenalidomide
Patents:27
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021880
Suppliers and Packaging for NDA: 021880
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVLIMID lenalidomide CAPSULE;ORAL 021880 NDA Celgene Corporation 59572-402 59572-402-28 28 CAPSULE in 1 BOTTLE (59572-402-28)
REVLIMID lenalidomide CAPSULE;ORAL 021880 NDA Celgene Corporation 59572-402 59572-402-00 100 CAPSULE in 1 BOTTLE (59572-402-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Dec 27, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 17, 2018
Regulatory Exclusivity Use:EXPANDED INDICATION FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
Regulatory Exclusivity Expiration:Feb 17, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Feb 22, 2024
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Expired US Patents for NDA 021880

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
US Department of Justice
Merck
McKesson
Fish and Richardson
US Army
Citi
Cerilliant

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